15. Appendix: up to two significant publications or achievements may be included in the appendix.(See NOT-OD-06-051)
2.G. PHS 398 Cover Letter File
PHS 398 Cover Letter File: Attach a letter agreeing to allow the X01 application to be shared with the MLSCN Steering Committee members. The letter should be brief and include the title of the application. The information in this application will be kept confidential.
The MLSCN Steering Committee, which consists of the Directors of the ten screening centers within the network, the Director of the Small Molecule Repository, and NIH staff, will develop a plan for distributing each HTS assay to a specific screening center based on existing capacity and expertise of each center as well as information such as assay target, cost, workload, detection system, etc. The MLSCN Steering Committee members will need to review the information in your application in order to make assay assignments to individual centers. No decision regarding the final assay assignment will be made without this letter of agreement.
Foreign
Organizations
Several special provisions apply to applications submitted
by foreign organizations:
- Charge back of customs and import fees is not allowed.
- Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11."
- Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.
- Organizations must comply with federal/NIH biosafety and biosecurity regulations..
Proposed research should provide
a unique research opportunity not available in the U.S. 3.A.1. Letter of Intent Although a letter of intent is
not required, is not binding, and does not enter into the review of a subsequent
application, the information that it contains allows IC staff to estimate
the potential review workload and plan the review. To permit expedited review of X01 applications, PD/PIs
are asked to notify the NIMH Referral Office by email when the application
has been submitted through Grants.gov. NIMH Referral Office 3.B. Electronic Transmission of an
Application to the NIH Upon receipt, applications will be transferred from Grants.gov
to the NIH Electronic Research Administration process for validation. Both
the PD/PI and the Signing Official for the organization must verify the submission
via Commons within two
(2) business days of notification of the NIH validation. Upon receipt, applications will be evaluated for completeness
by the Center for Scientific Review, NIH. Incomplete applications will not
be reviewed. There will be an acknowledgement of receipt of applications
from Grants.gov and the Commons.
Information related to the assignment of an application to a Scientific Review
Group is also in the Commons. 4. Intergovernmental Review PIs should submit a letter with their application, agreeing
to allow their application to be shared with the MLSCN Steering Committee
members. The information in their applications will be kept confidential.
This letter should be appended to Optional Components: PHS398 Cover Letter
File in the application package. The NIH requires the PD/PI to fill
in his/her Commons User ID in the PROFILE Project Director/Principal Investigator
section, Credential log-in field of the Research & Related Senior/Key
Person Profile component. The applicant organization must include its DUNS
number in its Organization Profile in the eRA Commons. This DUNS number must
match the DUNS number provided at CCR registration with Grants.gov. For additional
information, see Tips and Tools for Navigating Electronic Submission on
the front page of Electronic Submission of Grant Applications. Plan for Sharing Research Data Since the inception of the ML Roadmap, NIH has emphasized
that in order to yield the maximum benefit, all physical and intellectual
research resources should be publicly available. There are strong scientific
arguments supporting this position. Small molecule probes that selectively
interact with biological targets are key research tools for understanding
the functions of proteins and for elucidating biological pathways. A collection
of such probes that would allow the comprehensive study of all of the proteins
and other gene products encoded by the human genome would be an invaluable
contribution to biomedical research. It will take the combined efforts of
researchers in the public and private sectors many years of using small molecule
probes to completely characterize the biology of genes and proteins in health
and disease, and then to use that information to develop approaches that will
improve public health. Clearly, the open sharing of data, research tools,
and resources will lead more rapidly to the identification and validation
of novel targets for drug discovery, and will facilitate the rapid development
of therapeutics by both the private and public sectors, with resulting benefits
to public health, especially for rare or marginalized disorders. The willingness to comply with the NIH data sharing
plan or the rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing plan
into the determination of scientific merit or the priority score. It is NIH's understanding that the utility of the
resources and data generated by the ML initiative will be maximized if they
are treated as community resources and made broadly available, consistent
with achieving the goals of the ML Roadmap. While NIH recognizes that under
the Bayh-Dole Act, awardees have the right to elect title to subject inventions
and seek appropriate IP protection, the data sharing and IP plans should take
all of the above considerations into account. Applicants should provide clear
explanations and rationales for their plans, especially for any proposed plan
that involves principles differing from those described in this FOA. A separate component of the IP plan should address
any other data and resources that are expected to be generated by the grantees
under this FOA. NIH encourages applicants to consider inclusion of "non-assert"
language in IP plans for all potentially patentable inventions to ensure that,
while an institution might apply for a patent on an invention, the institution
would not attempt to enforce that patent against organizations utilizing the
technology for research purposes. NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131
). Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources will
be shared or explain why sharing is not possible. The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization and by NIH Project Team staff when making recommendations about
selecting assays for implementation within the MLSCN. Submitting investigators will be required to provide
necessary reagents such as cells expressing recombinant enzymes/proteins,
primary and secondary antibodies, tagged peptide substrates, and available
positive controls (e.g. a known inhibitor of the target). Submitting investigators and MLSCN Centers will be
expected to use an unmodified version of the Material Transfer Agreement (MTA)
approved by the MLSCN Steering Committee for transfer of assays and materials
to the individual MLSCN Centers (http://www.nimh.nih.gov/dnbbs/mta_10_31_2005.pdf). Section V. Application
Review Information 1. Criteria The following will be considered in making
selection decisions: The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and
to enhance health. In their written critiques, reviewers will be asked to
comment on each of the following criteria in order to judge the likelihood
that the proposed HTS assay will have a substantial impact on the pursuit
of these goals. Each of these criteria will be addressed and considered in
assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.
Significance. Does this study address an important
problem? If the aims of the application are achieved, how will scientific
knowledge or practice be advanced? Is this assay for a novel biological target
or cellular process? Is there no known small molecule modulator for this biological
target available? Is there a need for better small molecule modulators against
the target? Is this class of target extensively investigated? Is there an
adequate plan for evaluating the activities of the compounds identified in
a high throughput screen, e.g., in secondary screens and functional assays?
Are there important and well-defined goals for the use of small molecule compounds
identified with the proposed assay, either as research tools or for therapeutics
development? Approach. Is the assay well established and ready
for HTS? Is the assay pharmacologically validated? Is there sufficient preliminary
data for assay validation? Is there an assay performance parameter calculated,
such as Z-factor? Is the assay readily adaptable by screening centers to an
HTS format that is primarily characterized by miniaturization and automation?
Is the assay feasible and reproducible, and does it and meet minimum statistical
thresholds for robotic screening? Is there an adequate plan for assay reagents?
Are the assay reagents readily available from the applicant (s) if reagents
can not be commercially supplied? Is there an adequate plan for secondary
assays to evaluate active compounds identified in the primary assays? Innovation. Is the assay development project original
and innovative? For example: Does the assay challenge existing paradigms or
practice; address an innovative hypothesis or barrier to progress in the field
of HTS? Does the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area? Investigators. Are the investigators appropriately
trained and sufficiently knowledgeable about the target and area of science
to support the collaborative screening effort and capable of advancing active
compounds identified by the MLSCN? Are the investigators reasonably knowledgeable
and experienced about assay development and the process of screening compounds
library? Environment. Does the scientific environment of
the applicant (s) contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence
of institutional support? 2.A. Additional Review Criteria: Protection of Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed. See item 6 of the Research Plan component
of the SF424 (R&R). Biohazards: If materials or procedures are proposed
that are potentially hazardous to research personnel and/or the environment,
determine if the proposed protection is adequate. 2.B. Additional Review Considerations
Assay Access Review Committee (SEP): Evaluate assay proposals
for scientific merit and feasibility for HTS. The Scientific Review Administrator
(SRA) for this panel will be a NIH review staff member, and the panel members
will be primarily non-federal scientists. Recommendations of the Assay Access
Committee will be communicated to the NIH MLSCN Project Team and to the MLSCN
Steering Committee. NIH MLSCN Project Team: Review summary statements and develop
a balanced portfolio that is consistent with NIH-wide programmatic priorities.
The list of assay proposals will be presented to the MLSCN Steering Committee
for implementation within the screening centers network. Review the recommendations
of the MLSCN Steering Committee regarding the choice and distribution of assays
to specific centers and make final assignments of these assays to specific
centers and give final approval for assay assignments to individual centers.
MLSCN Steering Committee: Review HTS assay proposals selected
by NIH project team and develop a plan for distribution of assays to specific
centers within the screening centers network based on the NIH Project Team's
prioritization of assays acceptable for implementation, and information about
existing capacity and expertise of each center such as assay target, cost,
workload, detection system, etc. Budget:
Not applicable 2.C. Sharing Research Data
The adequacy of the resources sharing plan will be considered
by Program staff of the funding organization when making recommendations about
funding applications. Program staff may negotiate modifications of the data
and resource sharing plans with the awardee before recommending funding of
an application. The final version of the data and resource sharing plans negotiated
by both will become a condition of the award of the grant. Submitting investigators will be required to indicate whether
or not they have Material Transfer Agreements or Sponsored Research Agreements
in place to use patented technology or assay reagents proposed in this application
for non-commercial, research purposes. Investigators will be asked to provide
documentation prior to assay being selected for implementation within the
MLSCN. 3. Anticipated Announcement and Award
Dates Section VI. Award Administration Information 1. Award Notices If the application is under consideration
for selection, NIH will request the execution
of the MLSCN Material Transfer Agreement (MTA) i.e. signed by the institution
of the assay provider and a screening center as recipient. We encourage your inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
X01 application submission issues: 1. Scientific/Research Contacts: 3. X01 Submission Contacts: Section
VIII. Other Information Required Federal Citations This program is described in the
Catalog of Federal Domestic Assistance at http://www.cfda.gov/
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC
241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and
92. All awards are subject to the terms and conditions, cost principles, and
other considerations described in the NIH Grants Policy Statement.
The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
Weekly TOC for this Announcement
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission,
Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): Jan 26, 2007; May 26, 2007 and Sept 26, 2007.
Application Submission/Receipt Date(s): Feb 26, 2007; Jun 26, 2007 and Oct 26, 2007
Peer Review Date(s): April 2007; August 2007 and December 2007.
Council Review Date(s): September 2007; January 2008 and May 2008.
Earliest Anticipated Start Date(s): October 2007; February 2008 and June 2008.
Prospective applicants are asked to submit a letter
of intent that includes the following information:
The letter of intent is to be sent via email by the
date listed at the beginning of this document.
The letter of intent should be sent to:
Ingrid Li, Ph.D.
Molecular Libraries Assay Access Project Team
NIH Molecular Libraries & Imaging Roadmap
National Institute of Mental Health/NIH/DHHS
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD 20892-9641
Rockville, MD 20852-9641 (for express/courier
service)
Telephone: (301) 443-5288
FAX: (301) 402-4740
Email: [email protected]
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]
To submit an application in response to this FOA,
applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted to Grants.gov on or after the opening
date and must be submitted no later than 5:00 p.m. local
time (of the applicant institution/organization) on the application submission
date(s). (See Section IV.3.A. IV.3.A. for
all dates.) If an application is not submitted by the submission date(s) and
time, the application may be delayed in the review process or not reviewed.
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
6. Other Submission Requirements
Resubmissions (formerly called revised/amended) applications are not allowed.
Submit every application as a new application (or as a changed/corrected
application, if needed because of submission errors).
Data Sharing Plan: The reasonableness
of the data sharing plan or the rationale for not sharing research data may
be assessed by the reviewers. However, reviewers will not factor the proposed
data sharing plan into the determination of scientific merit or the priority
score. The funding organization will be responsible for monitoring the data
sharing policy. The presence of a data sharing plan will be part of the terms
and conditions of the award. Program staff of the funding organization and
NIH Project Team staff will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources will
be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Guidance for Community Resources. The following
data and materials generated or developed through the ML Roadmap initiative
are expected to be community resources: (1) primary data from HTS and from
secondary screens; (2) protocols for assays implemented in the MLSCN; (3)
the chemical structures of compounds tested in the MLSCN; and (4) the optimization
chemistry protocols for probe development conducted within the MLSCN centers.
In keeping with this approach, NIH expects that (1) all assays and assay protocols
submitted to the NIH under this FOA, and (2) biological screening data derived
from implementing the assays in the MLSCN will be made readily available and
accessible, consistent with other facets of the ML Roadmap http://grants.nih.gov/grants/guide/notice-files/NOT-RM-04-014.html
.
Only the review criteria described below will
be considered in the review process.
2. Review and Selection Process
Applications that are complete will be evaluated
for scientific and technical merit by an appropriate review group convened
by NIMH in accordance with the review criteria stated below.
As part of the initial merit review, all applications
will:
In addition to the above criteria, the following items will continue to
be considered in the determination of scientific merit and the priority score:
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under item 11 of the Research Plan component of the SF424 (R&R) should
be addressed.
Assay Review and Selection: The following is the anticipated process
for assay review and selection:
Data Sharing Plan: The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The funding organization
will be responsible for monitoring the data sharing policy. The presence of
a data sharing plan will be part of the terms and conditions of the award.
Program staff of the funding organization and NIH Project Team staff will
be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement
http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Not applicable
After the peer review of the application is completed,
the PD/PI will be able to access his or her peer review results and Summary
Statement (written critique) via the eRA Commons.
The Principal Investigator who submitted the assay
proposal will be notified by NIH staff if the assay has been selected for
implementation in a specific MLSCN center.
2. Administrative and National
Policy Requirements
Not applicable
3. Reporting
Not applicable
Section VII. Agency Contacts
Ingrid Li, Ph.D.
Molecular Libraries Assay Access Team
National Institute of Mental Health/NIH/DHHS
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD 20892-9641
Rockville, MD 20852-9641 (for express/courier
service)
Telephone: (301) 443-5288
FAX: (301) 402-4740
Email: [email protected]
2. Peer Review Contacts:
Yong Yao, Ph.D.
NIH Molecular Libraries & Imaging Roadmap
Scientific Review Branch
National Institute of Mental Health/NIH/DHHS
6001 Executive Boulevard, Room 6149, MSC 9608
Bethesda, MD 20892-9608 (20852 for overnight
couriers)
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: [email protected]
John Grossi
Scientific Program Analyst
National Institute of Mental Health
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD 20892-9641
Rockville, MD 20852-9641 (for express/courier
service)
Telephone: (301) 443-5288
Email: [email protected]
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use
of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
NIH Funding Opportunities and Notices
Department of Health
and Human Services (HHS)
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